Name: Predicase
Price: 199 USD

K-number	K011163
Device name	MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
Applicant	Syva Co., Dade Behring, Inc.
Product code	JXN
Device class	Class II
Decision date	May 10, 2001
Decision	Substantially Equivalent
Regulation	862.3700

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229

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